Vietnam’s Ministry of Health (MoH) issued Circular No. 01/2018/TT-BYT (Circular 01) on January 18, 2018, regarding regulations on labeling of pharmaceutical products. The Circular 01 will replace current regulation Circular No. 06/2016/TT-BYT (Circular 06) and will be in effect from June 1, 2018.
The recent Circular includes guidelines regarding:-
- Labels of finished product drugs and drug raw materials;
- Package inserts of finished drugs; and
- Change in the shelf life indicated on the label of finished drugs in certain cases.
Finished drugs packaged inserts
Package insert contains detailed drug information compiled and distributed by the drug manufacturer. Its purpose is to provide a complete prescribing and safety information to health professionals. As of now, the package insert (PI) includes two separate sections, each with information for healthcare professionals and patients.
Now, as per Circular 01, it will include only one section with information for both patients and healthcare professionals.
Replacement of PI after import
As per current regulations, once a finished drug is imported in Vietnam, the PI cannot be supplemented or replaced. However, under the new regulations, this condition has been removed, allowing a PI to be replaced or supplemented in Vietnam under certain conditions such as:
- Drugs imported with Marketing Authorization (MA) licenses having Vietnamese-language PIs, but not updated as per MoH guidelines; and
- Drugs imported with import licenses without Vietnamese-language PIs.
Under Circular 01, offshore manufacturers will not be responsible for labeling.
- In the case of a drug with MA license, the importer and MA holder will be responsible. As per current regulations, both the manufacturer and the MA holder are responsible.
- For drugs with an import license, only the importer will be responsible. As of now, the manufacturer is also responsible.
Circular 01 will be in effect from June 1, 2018. As of now, drugs granted registration certificates or import permits before the effective date of the Circular, can be sold with MoH approved labels and PIs until the expiry of MA license.
Applicants who have submitted drug registration or import dossiers to the Drug Administration of Vietnam (DAV) before June 1, 2018, and awaiting approval, can submit additional dossiers to the MoH requesting to update the information on drug labels and instructions in accordance with the provisions of Circular 01. If updated documents are not submitted, the label and PI will be considered as per current regulations in Circular 06. However, once the license is issued, the license holder must update the label contents and use instructions as prescribed under Circular 01 within six months from the date of issue of the MA license.
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